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NCT Number: NCT07221214

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are:

1. Does semaglutide lower the average number of alcoholic beverages participants drink per week? 2. Does semaglutide lower the average number of cigarettes participants smoke per day? 3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco?

Researchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week.

Participants will:

1. Take semaglutide for 3 months 2. Visit the research clinic 3 times for checkups and tests 3. Provide blood samples, stool samples, and saliva samples for tests.

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Key information

Conditions

HIV Alcohol Behavior Cardiovascular Disease Prevention Cardiovascular Diseases Cigarette Smoking Smoking Smoking Cigarette Tobacco Smoking Tobacco Use

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Rachel Jones, MS

CONTACT

[email protected]

615-421-3508

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-89
  • Prior diagnosis of HIV-1
  • Affiliated with Vanderbilt Comprehensive Care Clinic
  • On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.
  • Most recent absolute CD4 count ≥ 300 cells/mm3 and drawn within 12 months of study enrollment
  • BMI ≥ 23 (calculated at screening)
  • Self-report of consuming alcohol in past 90 days
  • AUDIT-C ≥ 3 (male)/ ≥ 2 (female)
  • Has an established stable address at which they can receive mail and can be reached for the next 6 months
  • Willing and able to complete study procedures and follow-ups

Exclusion criteria

  • Known allergy to semaglutide
  • Currently taking GLP-1 RA (in the past 3 months)
  • History of diabetes defined by diagnosis in Problems List in medical record
  • History of pancreatitis
  • History of gastroparesis
  • Gallbladder disease (in the past 3 months)
  • History of medullary thyroid carcinoma
  • Family history of medullary thyroid carcinoma
  • History of multiple endocrine neoplasia syndrome type 2
  • Family history of multiple endocrine neoplasia syndrome type 2
  • Cognitive inability to consent
  • Barrier to speaking, hearing, reading, or writing English
  • Pregnant or breastfeeding, or planning to become pregnant in the next 6 months
  • Too ill to complete study procedures

Treatment and study plan

Semaglutide (Rybelsus®)

Drug

experimental study medication

Placebo

Drug

Placebo study product

Primary outcomes

  1. Average drinks/week past 30 days at 3 months

    Time frame: 3 Months

    Average drinks/week past 30 days (via Timeline Follow Back (TLFB))

Secondary outcomes

  1. Average cigarettes per day (cpd) past 30 days at 3 months

    Time frame: 3 Months

    Average cigarettes per day in the past 30 days (via TLFB)

  2. Systemic inflammation (IL-6) at 3 months

    Time frame: 6 Months

    Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk

Study contacts

Contact information is provided by the study sponsor or research team.

Hilary A Tindle, MD, MPH

CONTACT

[email protected]

615-875-9726

Rachel Jones, MS

CONTACT

[email protected]

615-421-3508

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Norton Healthcare
  • University of Louisville

Registry information

Official study title

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT

Acronym: GL1DER HIV RCT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Oct 27, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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